Periodontal interdental delivery tray and periodontal medicament tray syringe

ABSTRACT

The present invention relates to a periodontal interdental tray and to a periodontal medicament tray syringe that can be used in conjunction with the periodontal interdental tray of the present invention, or can be utilized by itself or in conjunction with other periodontal trays already on the market. In one embodiment, the present invention relates to treatment of periodontal disease, and in particular to a dental tray syringe and method for delivering medicaments into areas of the mouth either supragingival or subgingivally to treat the infected areas.

RELATED APPLICATION DATA

This patent application is a divisional of U.S. patent application Ser.No. 12/842,697, filed on Jul. 23, 2010, and entitled “PeriodontalInterdental Delivery Tray and Periodontal Medicament Tray Syringe”,which claims priority to U.S. Provisional Patent Application No.61/228,287, filed on Jul. 24, 2009, and entitled “Periodontal TraySyringe” and U.S. Provisional Patent Application No. 61/228,124, filedon Jul. 23, 2009, and entitled “Periodontal Interdental Tray”, theentireties of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a periodontal interdental tray and to aperiodontal medicament tray syringe that can be used in conjunction withthe periodontal interdental tray of the present invention, or can beutilized by itself or in conjunction with other periodontal traysalready on the market. In one embodiment, the present invention relatesto treatment of periodontal disease, and in particular to a dental traysyringe and method for delivering medicaments into areas of the moutheither supragingival or subgingivally to treat the infected areas.

BACKGROUND OF THE INVENTION

Periodontal (gum) disease affects a majority of adults at some time intheir lives, usually having no warning signs until advance stages of thedisease state exist. Treatment methods depend upon the type of diseaseand how far the condition has progressed. When periodontal pocketsbecome greater than 3 mm between teeth and gums, it is difficult orimpossible for the patient to thoroughly remove plaque and tartar. Whileprofessional dental cleanings can clean periodontal pockets that existin the range less than 5 mm, surgery may be necessary to reduce thedepth of the pockets or to restore or reshape bone that has beendestroyed and create an architecture that is conducive to cleaning. Inan attempt to avoid such invasive dental or dental surgical procedures,treating the affected areas with antibacterial or antimicrobial agents(i.e., chemical, antibiotic, or other pharmacological agents) to restoreperiodontal health have been developed and are being performed. Suchantibacterial or antimicrobial agents have been found to control or stopthe growth of bacteria that create toxins and cause periodontal diseaseand encourage normal healing, thereby reducing the necessity or theinvasiveness of periodontal or oral surgery. Problems arise that thefrequency of administration of these drugs is not practical, seeing theyneed to be done in the dental chair by a trained dentist or dentalhygienist. Other means of cleaning these periodontal pockets includemanual brushing of the periodontal pocket using small brushes orinterdental brushes. Problems with current interdental brushes is thatthe patient has a very difficult time finding the periodontal defects,and even when found, access is not easy, due to their location,position, or depth. When multiple sites exist in various locations, thetask becomes impossible to perform with accuracy and enough frequency.

Several methods have been developed for treating periodontal diseasethat enable medicament to be delivered to the infected site below thegingiva. For example, U.S. Pat. No. 5,085,585 discloses an applicator ofdental medicament and method of use.

Additionally, as set forth in U.S. Pat. No. 5,330,357 describesmedicaments that can be delivered in close proximity to the bone andsupporting structure of the teeth by flossing using tufted floss,brushing using an interdental brush, injection using a syringe, or byhydrostatic or mastication pressure using a dental tray. Dental traysoften are constructed from a soft plastic elastomeric material that ismolded in place to a patient's teeth so as to firmly and closely fit inplace on the patient's teeth, and a seal is made to hold the traysolidly against the dental tissues. Medicament is placed in recessesformed in the tray that are adapted to accommodate the patient's teeth,and then guided or forced along the teeth and into the gingiva by thesealing means to the infected site as the patient closes his jaw on thetray. A propulsion agent such as hydrogen peroxide also can be placed inthe recesses to guide or force the medicament into the infected site asthe hydrogen peroxide breaks down and increases the pressure within therecesses.

Other examples of dental trays are set forth in U.S. Pat. Nos.4,902,227; 4,428,373; and 4,138,814. While these types of dental traysdo allow for application of the medicament subgingivally, none of thesereferences connect the periodontal pocket to a cannula leading outsideof the mouth.

U.S. Pat. No. 3,874,084 discloses a molded tooth cleansing and gingivaltherapeutic device that includes a plurality of bristles projectinginwardly from the inner walls of the upper and lower channels of a tray.The bristles are provided to clean food particles and bacteria from thesurfaces of a user's teeth and the gingival crevices. The walls of thechannels are of a sufficient thickness to form ridges or ledgesextending away from the gingival lines. These ridges compress thegingiva to allow for cleansing of the gingival crevice between the teethand gum and massaging of the free marginal gingival.

U.S. Pat. No. 6,966,773 discloses dental tray and method for treatmentof periodontal disease that provides a seal around teeth associated withthe infected area to guide or force medication onto the surface of theteeth and subgingivally into the infected area and a propulsive agentsuch as peroxide.

What all these systems do have failed to achieve is a true micro syringethat can be loaded like a similar syringe, and use force from a plungerto inject medicaments into multiple periodontal sites. One of the majorfailures of inventors of trays in the past is that their trays do nottruly inject medicaments and rely on weak physical properties that donot allow medicaments to enter diseased pockets. Some systems of theprior art even rely on claims of propellants used to push medicamentsinto periodontal sites, relying exclusively on oxygen releasingcompounds such as peroxide, which may not be desired to be mixed withother therapeutics such as antibiotics such as Arestin, or Atridox.Companies that sell drugs such as Arestin, or Atridox approved by theFDA for in-office administration have achieved little success due to thefact that these drugs were designed for in-office delivery with weeksbetween dosings. For example, systemic antibiotic dosing is 4 times perday for 10 days by the patients at home. This is impractical due to thepatient's inability to go to the dentist for 40 visits over a 10 dayperiod. Such a tray system and method of treatment easily andconveniently allows therapeutics to be administered by the patient,without special training or undue skill, and not need to be worn forextended periods of time at each application.

Given the above, there is a need in the art for an improved periodontalinterdental tray and/or a syringe that permits the more effectivetreatment of periodontal conditions.

SUMMARY OF THE INVENTION

The present invention relates to a periodontal interdental tray and to aperiodontal medicament tray syringe that can be used in conjunction withthe periodontal interdental tray of the present invention, or can beutilized by itself or in conjunction with other periodontal traysalready on the market. In one embodiment, the present invention relatesto treatment of periodontal disease, and in particular to a dental traysyringe and method for delivering medicaments into areas of the moutheither supragingival or subgingivally to treat the infected areas.

In one embodiment, the invention described here allows for repeatabledelivery of medicaments into a periodontal pocket through the creationof a true syringe when using the invention with a plunger pushed througha tube into the periodontal pocket. In another embodiment, the presentinvention also permits for repeatable curettage using fine instrumentspushed through the tubes into the periodontal pocket. In still anotherembodiment, the present invention permits for the repeatable lavage, byusing the tube to connect a source of medicated or non-medicated liquidsenergized, or not, directed into the periodontal pocket.

In another embodiment, the present invention relates to a periodontaltray system comprising: a first inner tray layer that is designed toconform to at least a portion of an individual's mouth, wherein thefirst inner tray layer is designed to have one or more indentations, orpockets, formed therein that correspond to at least one area ofperiodontal disease; and a second outer tray layer that is designed tooperatively engage the first inner tray layer, wherein the one or moreindentations, or pockets, formed in the first inner tray layer containone or more medicaments, or compounds, designed to treat one or moreaspects of periodontal disease, and wherein the second outer tray layeris designed to operatively engage the first inner tray layer so as topermit the delivery of the one or more medicaments, or compounds,contained in the one or more indentations, or pockets, formed in thefirst inner tray layer into the at least one area of periodontaldisease.

In still another embodiment, the present invention relates to aperiodontal tray system comprising: a first tray layer that is designedto conform to at least a portion of an individual's mouth, wherein thefirst inner tray layer is designed to have one or more openings thereinthat correspond to at least one area of periodontal disease, wherein theone or more openings formed in the first tray layer are designed tooperatively couple one or more syringes, or micro-syringes, and whereinthe one or more syringes, or micro-syringes, contain one or moremedicaments, or compounds, designed to treat one or more aspects ofperiodontal disease.

In still another embodiment, the present invention relates to aperiodontal tray system comprising: a first tray layer that is designedto conform to at least a portion of an individual's mouth; and one ormore openings formed in the first tray layer, wherein the one or moreopenings correspond to at least one area of periodontal disease, whereinone or more openings formed in the first tray layer are designed tooperatively couple with one or more devices designed to provide one ormore medicaments, or compounds, designed to treat one or more aspects ofperiodontal disease.

In still another embodiment, the present invention relates to a methodto fabricate the periodontal tray system, the method comprising thesteps of: (i) placing one or more small barbed broaches into one or moreperiodontal pockets, wherein the one or more small barbed broaches aredesigned to function in conjunction with a dental molding material, orimpression material, that is used to duplicate various teeth and mouthstructures; (ii) creating a mold of one or more areas surrounding theone or more periodontal pockets, wherein the mold contains one or moreopenings formed therein that correspond to the placement of the one ormore small barbed broaches; and (iii) using the mold of Step (ii) aseither a periodontal tray, or as an impression to produce a periodontaltray, wherein the periodontal tray contains one or more openings thereinthat correspond to one or more periodontal pockets, wherein the one ormore openings are designed to connect to one or more treatment devices(e.g., a tube/syringe combination, or a syringe).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a tooth;

FIG. 2 is a close-up illustration of the root of a portion of a toothand the surrounding bone structure;

FIG. 3 is a close-up illustration of a portion of a tooth and gum areathat suffers from periodontal disease showing a probe therein that isutilized to determine the extent of the periodontal disease;

FIG. 4 is a close-up illustration of a portion of a tooth and gum areathat suffers from periodontal disease showing a device designed to treatand/or manage periodontal disease, wherein the device is formed inaccordance with one embodiment of the present invention;

FIG. 5 is a cross-sectional illustration of a tooth and surrounding gumarea that suffers from periodontal disease showing a device designed totreat and/or manage periodontal disease, wherein the device is formed inaccordance with one embodiment of the present invention;

FIG. 6 is a cross-sectional illustration of the device of FIG. 5, wherethe device has been deployed;

FIGS. 7A through 7C are illustrations of multiple layers of traymaterials as they exist in various configurations;

FIGS. 8A through 8B are illustrations of various layers of traymaterials with a capsule medicament ring that is used to hold medicamentcapsules;

FIGS. 9A and 9B are illustrations of a micro-spring loaded syringe thatattaches to a tray layer;

FIG. 10 is an illustration of one embodiment of a periodontal tray ofthe present invention that contains one or more openings that aredesigned to engage one or more syringes;

FIG. 11 is an illustration of a barbed broach placed in the periodontalpocket defect;

FIG. 12 is an illustration of two tray layers, one that receives amedicament capsule and holds it intimate to the gum/tooth surface and asecond layer that crushes it and expels its contents; and

FIGS. 13A through 13F are flow charts representing various methods thatfall within the scope of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a periodontal interdental tray and to aperiodontal medicament tray syringe that can be used in conjunction withthe periodontal interdental tray of the present invention, or can beutilized by itself or in conjunction with other periodontal traysalready on the market. In one embodiment, the present invention relatesto treatment of periodontal disease, and in particular to a dental traysyringe and method for delivering medicaments into areas of the moutheither supragingival or subgingivally to treat the infected areas.

In one embodiment, the invention described here allows for repeatabledelivery of medicaments into a periodontal pocket through the creationof a true syringe when using the invention with a plunger pushed througha tube into the periodontal pocket. In another embodiment, the presentinvention also permits for repeatable curettage using fine instrumentspushed through the tubes into the periodontal pocket. In still anotherembodiment, the present invention permits for the repeatable lavage, byusing the tube to connect a source of medicated or non-medicatedliquids, energized or not, directed into the periodontal pocket.

In another embodiment, the present invention is a periodontalinterdental delivery tray system fitted to one or more teeth of apatient's upper and/or lower dental arch provided for the application ofmedications to the teeth or gum tissue, bone or periodontal ligament fortreatment of periodontal disease. The tray system described can guidecleaning brushes or other interdental periodontal aids into one or moreperiodontal pockets. The tray system can also direct streams of liquids,medicated or not, into the periodontal pockets. The trays areconstructed from a variety of resilient materials molded to conform tothe teeth, gum tissues, and jaws. The interdental tray system includesat least one layer of material, but can include multiple layers, moldedinto trays that are compressible and resilient thereby permitting theone or more trays of the present invention to return to their originalshape(s) after deformation.

In one embodiment, the overall tray system of the present inventioncomprises a first tray layer that is formed from an impression of apatient's mouth, or a portion thereof, where the impression permits thetray system to contain one or more impressions that correspond to theone or more periodontal pockets that may exist in a patient's mouth. Inone embodiment, the present invention permits a fitting to be affixed toeach impression (or hole). The fitting can be designed to either receivea liquid, periodontal aid, or liquid stream.

In another embodiment, the one or more fittings can connect to one or aseries of tubes or cannulae. These tubes can be connected to anadditional fitting that can either be alone or arranged in a row.Through each opening of the fitting connected to the tube connected tothe fitting affixed to the tray, a liquid or micro brush, or pressurizedliquid spray, or sonically energized liquid stream, medicated or not,can be pushed, injected or supplied to a desired area for the purposesof effecting a treatment. Methods for fabricating the trays in the trayinterdental system, loading the trays with medicaments, delivering themedicaments into the periodontal pocket or defect, pushing liquidsthrough the tray, and or inserting micro periodontal aids into theperiodontal pockets will be described below.

A tray syringe system fitted to one or more teeth of a patient's upperor lower dental arch provided for the application of medications to theteeth or gum tissue, bone or periodontal ligament for treatment ofperiodontal disease. The trays are constructed from a variety ofresilient materials molded to conform to the teeth, gum tissues, andjawbones. The tray syringe system includes at least one layer ofmaterial, but can include multiple layers, molded into trays that arecompressible and returns to its shape after deformation. The first traylayer when formed acts as a receptacle for medicaments. The receptacleor receptacles are fabricated in positions specifically desired by thedentist or physician corresponding to where the periodontal disease siteis, either on the tooth, gums, or bone surrounding the tooth. Thereceptacle may resemble a bulb that when compressed will expel itscontents into the periodontal pocket, or defect. Upon installation ofthe first tray layer on the patient's teeth, the medication sits anddoes not leave the bulb or receptacle, allowing for the tray to positionexactly where it needs to be to be effective. A second tray is thenfabricated that fits over the first tray made out of a more rigidmaterial that when positioned over the first tray pushes on themedicament bulb chamber, expelling the contents into the desired place.This tray syringe can be composed using more than two layers, such as athird layer that acts as a focusing layer or micro-needle or cannula.When positioned before or in front of the layer containing themedicament, it can guide the medicament into the periodontal pocket ordefect. As the third tray engages the medicament tray, which is now thesecond tray, the medication is forced onto the surface of the teeth andsubgingivally by the seal into any pockets in the patient's gumsproximate the teeth. The first tray layer acts as the barrel of thesyringe holding the medicament. The second tray layer, which fits overthe first tray layer and is compressed against it acts as the plunger.The system can have a third layer that directs the medicament into amore focused delivery acting as the needle. Methods for fabricating thetrays in the tray syringe system, loading the trays with medicaments,and delivering the medicaments into the periodontal pocket or defect arealso described herein.

One object of the present invention is to provide an improvedperiodontal medicament delivery tray system, and method for treatingperiodontal disease by providing portal from outside the mouth into theperiodontal pocket for introduction of either cleaning tools or cleaningliquids or medicaments. Thus, as noted above, in one embodiment, thepresent invention relates to a tray system composed of one or morelayers of material that when combined and used in conjunction with eachother work as periodontal aid which is fitted to one or more teeth of apatient's upper or lower dental arch provided for the application ofmedications to the teeth or gum tissue, bone or periodontal ligament fortreatment of periodontal disease.

Another facet of the present invention is that the tray allows for theintroduction of an interdental cleaning device and guides a cleaningobject or medicament into the periodontal pockets, repeatable and in theexact location every time. The same tray can be attached to a liquidsource that directs liquid streams into the periodontal pockets. Thetrays are constructed from a variety of resilient materials molded toconform to the teeth, gum tissues, and jaw bones, including at least onelayer of material, but can include multiple layers, molded into traysthat are compressible and returns to original shapes after deformation.

The first tray layer when formed has one or more holes drilled orfabricated directly above, or proximate to, one or more periodontaldefect(s)/pocket(s) using a periodontal charting for positioning of theentries into the periodontal defects. Once the desired area, or areas,needing treatment are marked on a dental cast of the patient, a fittingis affixed to each hole in the tray using a glue, acrylic, or othermeans of mechanical friction or sandwiching the fitting between twolayers of the tray. A connection from the fitting is then attached to atube, hose, cannula made from disposable rubber goods. These tubes canbe connected to an additional fitting on the other side to allow for apolished edge and or an additional plumbing connection to be utilized.

If a doctor needs to treat multiple periodontal pockets resulting inmultiple holes drilled, multiple fittings will be attached with multipletubes. These tubes can be attached to a plastic or metal framework canbe used to gang these tubes together in a row. This assembly can beattached to the tray or hand from the tray. The assembly housingmultiple tubes can be numbered or marked identifying the areas usingcolors, or symbols aiding the end user in working with the appliance.Through each opening of the fitting connected to the tube connected tothe fitting affixed to the tray, a liquid or micro brush, or pressurizedliquid spray, or sonically energized liquid medicament stream can bepushed deeply into the periodontal pocket resulting in lavage orcurettage. Such form of cleaning will not harm the tissues with in theperiodontal pocket such as tooth cementum that is necessary forre-building of bone creating a new attachment to the tooth. The fittingsattached to the tray that communicate with the oral cavity can be loadedlike a gun with medicaments which can then be plunged through the tubeinto the periodontal defect, or through use of a propellant like air, ora jet stream from a compressed gas container. The tray system can beused with any medication used to treat periodontal disease or otherdisease of the mouth. Examples of such medicaments include, but are notlimited to, antimicrobial agents, steroids, antifungal agent,sterilants, conditioners, fluorides, dentin desensitizers, antivirals,anesthetics, oxygenases, enzymes, peroxides, and therapeutic bacterialstrains, any suitable combination of two or more thereof, or others.

The tray system of the present invention can be adjusted orre-fabricated according to the stage of periodontal disease suffered bythe patient by creating more than one tray as the treatment progresses.Gingival tissues that are swollen may shrink and therefore the openinginto the periodontal pocket may move from where the first tray isfabricated. When constructing the tray, the first layer of the traysystem is constructed from a cast representative of the patient's teethand surrounding gum tissue created from either a digital scan of thepatient's mouth or any type of dental impression using any suitabledental impression material.

The tray system of the present invention can also be fabricated to holdin contact to the periodontal pocket one or more unit-dose medicamentcapsules that when crushed against the tooth/gum surface and the tray,releases medicaments into the areas to be treated.

Turning to a detailed discussion of the present invention, initially adetailed periodontal examination is performed on a patient by a licenseddentist, dental hygienist or periodontist. A periodontal charting isperformed. Periodontal pockets that are deeper than 3 mm are highlightedand marked. Dental impressions are taken of the patient and stone castsare poured up in dental stone. The periodontal chart is then reviewedand the areas of the tooth/gingiva surfaces in which dental pocketsdeeper than clinical acceptance are marked on the stone casts using anink pen. This marked cast is now used to fabricate the tray syringe on.

Another method for more accurately reproducing the periodontal pocketlocation and opening is also described. A detailed periodontalexamination is performed on a patient by a licensed dentist, dentalhygienist or periodontist. A periodontal charting is performed.Periodontal pockets that are deeper than 3 mm are highlighted andmarked. Small, flexible barbed broaches or points are now inserted intothe actual periodontal pockets in the mouth. These broaches or pointseither stay in place due to the depth of the pocket or defect, or areheld in place the application of a curable composite resin. Dentalimpressions are taken of the patient and stone casts are poured up indental stone. In all locations where a broach or point were placed, ahole in the cast will be present indicating not only the location of theperiodontal disease, but a detailed access hole will be present allowingthe tray syringe fabrication to be more accurate than conventionalimpression techniques with a transfer from a periodontal chart.

Fabrication of the first tray layer is the next step. Once the dentalcast is fabricated with the access areas either marked on the cast oractually created in the stone using the broach-impression technique, asmall shape is placed on the dental cast used a framework for the firstlayer of tray material.

A two layer bulb tray can now be fabricated by placing dental compositeresin injected from a syringe in the shape of a ball or ovoid shape tocreate the framework for the soon to be created bulge or recess thatwill form in the first tray layer. Due to composite resins ability tostick to the dental model and harden after curing, it makes forexcellent material to place on the stone cast. Another method to createthe same effect is to take air gun BBs from a local hobby store, andglue them to the cast using superglue. Salt or sugar or other watersoluble formulations that can go from the solid state and easilydissolve in water can be formed in a desired shape and used in place ofthe composite resin or BB. Once all the BBs, or composite resin balls,are attached to the dental cast of the patient's mouth vacuum-formedheated EVA material heat suck-down is made over the cast with theprojections. This now becomes the first tray layer. It should be notedthat although the first tray layer is disclosed to be formed from EVAthe present invention is not limited thereto. Rather, any other suitableflexible and/or resilient polymer or plastic compound can be utilized solong as such a compound is able to be placed in an individual's mouth.

The first tray layer is now removed from the cast and any excessmaterial is removed. The first tray layer is now placed back on themodel and an impression is taken of it using alginate impressionmaterial. After the impression of the first tray layer on the cast istaken, it is poured up dental stone. A knife is now used, or a spinningcutting bur on a dental motor is used, to abrade or divot or dent orremove the budges or positives in the stone cast which represent therecesses or bulbs of the first tray layer. This stone cast is now placedin the dental vacuum form machine and a second layer of a harder plasticmaterial is vacuum-formed over the cast. When this layer is removed fromthe cast, trimmed and placed over the first tray layer it becomes asecond tray layer of the present invention. The second tray layer isdesigned to depress the recesses in the flexible EVA material and expeltheir contents. The medicament of choice is now syringed into the firsttray layer's bulge or recess using a standard medical syringe having aneedle. The first syringe layer is loaded with medicament and is placedinto the mouth firmly seating it over the teeth and gingival. The fitshould be firm and stable. Now the second tray layer which is designedto be the harder tray layer is placed over the first layer and pushed upback and forth by the patient's hands. The motion can be one swiftmotion, or a pumping motion. Once the medicament is delivered, the traysyringe can be removed and cleaned for the next application.

A three layer bulb tray can also be fabricated with a slightmodification. Prior to placing the resin or BB on the cast to create abulge for the medicament, a layer of EVA is first thermoformed over thecast. Then holes are drilled to communicate to the periodontal pockets.Then the BBs or composite resin are placed in the holes drilled throughthe EVA layer. A second layer of EVA is then thermoformed over the firstlayer, sandwiching the BBs or composite resin between the two layers.The two fused layers are then removed and the BBs or composite resinballs are pushed through the holes, leaving a recess or bulb to acceptthe medicament. The steps are the same in then fabricating the hardplunger layer as the two layer bulb tray discussed above.

A two layer capsule tray can be fabricated by substituting the BBs orcomposite resin with a hard replica of a micro unit-dose medicamentcapsule. Following the same fabrication instruction as the two layerbulb tray, the hard replica creates the cavity for the unit-dosecapsules to load into.

A one layer Lavage tray is also within the scope of the presentinvention. In one embodiment, a hard thermoformed plastic material isformed over the dental cast that is marked showing the periodontalpockets. Holes are drilled through the hard plastic in order tocommunicate with the pockets openings on the cast. Couplings are fittedand affixed to the hard tray layer that will accept cannulae. Anirrigation source is attached to the cannulae and provides site specificdirected irrigation. These cannulae can be ganged together as to allowthe user easy attachment to the irrigant liquid or can be daisy chainedor ran in parallel to allow the irrigant to reach multiple pockets atthe same time.

A one layer curettage tray is also within the scope of the presentinvention. In one embodiment, a hard thermoformed plastic material isformed over the dental cast that is marked showing the periodontalpockets. Holes are drilled through the hard plastic in order tocommunicate with the pockets openings on the cast. Couplings are fittedand affixed to the hard tray layer that will accept cannulae.Micro-instruments attached to fishing line can then be thread throughthe cannulae reaching the periodontal pockets in the mouth. Thesecannulae can be ganged together as to allow the user easy access tomultiple pockets by simply moving the micro instruments through theganged cannulae. This tray can be also used to push medicaments deepinto the periodontal pockets by loading medicaments into the end of thecoupling touching the periodontal pocket opening and using a plungerattached to the fishing line filament to push the meds deep into long 4to 10 mm pockets.

Due in part to the method by which the present invention is fabricated,a periodontal tray is produced that permits one to guide a cleaningobject, or medicament, into one or more periodontal pockets in arepeatable and exact manner as desired by a doctor, or other treatmentprofessional.

In another embodiment, the interdental tray system of the presentinvention includes at least one layer of resilient material, but caninclude multiple layers of resilient material, molded into trays thatare compressible and return to their original shapes after deformation.Trays can be fused together, or can fit together and can be separated.

In another embodiment, the one or more pockets formed in the flexiblefirst tray layer of the present invention can be individually, orcollectively, replaced, or supplemented, by one or more holes, oropenings, that are designed to communicate with one or more periodontaldefect(s) or pocket(s). This permits the periodontal tray system of thepresent invention to function in conjunction with one or more syringesthat can be used to inject one or more medicaments into a periodontalpocket.

Turning to the Figures, FIG. 1 is an illustration of a tooth 1 having aroot 2 secured by surrounding bone 3 and gum 4. As can be seen in FIG.1, a periodontal pocket 5 exists one side of the tooth 1 that exposes aportion of the root surface 8 of tooth 1. FIG. 2 is a close-upillustration of the tooth root 2, the surrounding bone 3, diseased areaof the gum 4, and the exposed root surface 8. The periodontal pocket isrepresented by reference numeral 5. FIG. 3 is a close-up illustration ofa tooth with a root 2 with a periodontal pocket 5 being measured with aperiodontal probe 20. In system of FIG. 4, first tray layer 6 is formedfrom the resilient material, as is discussed above, and contains thereinone or more pockets, indentations, or cavities 7 that correspond inlocation to periodontal pocket 5. The one or more pockets, indentations,or cavities 7 can be filled with one or more medicaments or compounds asdisclosed above. Filling can be accomplished by any suitable mannerincluding, but not limited to, a syringe. As is discussed above theperiodontal tray system of the present invention, as represented in partby FIG. 4, also comprises a second tray layer 9 that may, or may not,contain one or more internal protrusions 10 designed to operativelyengage a respective and/or corresponding pocket, indentation, or cavity7. In the instance where second tray layer 9 comprises one or moreinternal protrusions 10 (see FIG. 4), the one or more internalprotrusions 10 are designed to provide additional impetus for therelease of the one or more medicaments contained in a respective and/orcorresponding pocket, indentation, or cavity 7. However, the one or moreinternal protrusions 10 are not required in all embodiments of thepresent invention. In another embodiment, such protrusions 10 may beabsent where the patient, or some other individual, provides thenecessary pressure to cause the ejection of the medicament contained inthe one or more pockets, indentations, or cavities 7 to be ejected. Inone embodiment, the one or more compounds, or medicaments, contained inthe one or more pockets, indentations, or cavities 7 of the first traylayer of the present invention can be in a gel form so as to stay putuntil dispensing thereof is desired. In another embodiment, the one ormore compounds, or medicaments, contained in the one or more pockets,indentations, or cavities 7 of the first tray layer of the presentinvention can be in a liquid form where the one or more pockets,indentations, or cavities 7 are designed to have a slightly smalleropening at the internal surface so as to take advantage of a liquidsurface tension property.

Turning to FIGS. 5 and 6, FIGS. 5 and 6 illustrate a completecross-sectional view of one tooth with a periodontal tray system of thepresent invention located there over. In FIG. 6, layer 13 corresponds tofirst tray layer 6 expect for the fact that pocket, indentation, orcavity 7 has been compressed by second tray layer 9. As would beapparent to those of skill in the art, a wide variety of sizes andshapes of the periodontal tray system of the present invention can beproduced. As such, the present invention is not limited to completemouth (upper and/or lower) trays. Instead, any shape of a partial trayor complete tray can be accomplished using the information disclosedherein. Protrusion 10 acts to engage pocket, indentation, or cavity 7 soas to accomplish the release of the one or more medicaments, orcompounds, contained therein.

Turning to FIGS. 7A through 7C, these Figures are illustrations showingmultiple configurations of tray materials. The tooth/gum surface islabeled 8. The hard, or second tray layer 9 with one or more protrusionsand/or indentations 10 located therein are situated in such a positionso that protrusion and/or indentation 10 pushes on the softer, or first,tray layer 6 thereby releasing medicament either directly as shown inFIG. 7A, or through an intervening layer 11 that is located betweenlayer 6 and the surface of the tooth/gum 8 (see FIG. 7B). FIG. 7Cillustrates an embodiment where a focusing needle 12 is located betweenlayers 6 and 11.

Turning to FIGS. 8A and 8B, FIG. 8A illustrates a medicament capsuleholder I having flanges B and a medicament portion J, whereas FIG. 8Billustrates the medicament capsule holder sandwiched between two traylayers Y and Z. The medicament capsule holder I is secured, ormaintained, in place by flanges B formed therein. The hard, or second,tray layer W crushes the capsule I thereby releasing medicament Q whenlayer W is pushed up against the medicament portion J.

FIGS. 9A and 9B illustrate a mechanical micro-syringe that attaches tothe tray layers of a two layer system described above. As a barrel F iscompressed against a spring C, latch D engages the side of the syringe Eand energizes. When a hard tray or instrument comes in contact withlever D, the spring pushes the barrel F down and releases the medicamentH.

Turning to FIG. 10, FIG. 10 illustrates a periodontal tray system of thepresent invention that contains only a first resilient layer 6 asdescribed above. In this embodiment, tray layer 6 contains one or moreholes, or openings in which a coupling or fitting is attached 18 thatcan be operatively engaged with one or more cannulae 30 that attaches toone or more syringes 17. As would be apparent to those of skill in theart, multiple opening, or holes, 18 could be operatively coupled, orengaged, to one syringe 17 through a series of multiple tubes orcannulae 30 connected to the end of a syringe. In another embodiment,syringe 17 can be replaced by a syringe, or a squeeze bottle orcontainer that is designed to be decupled from the supply line that isin connection with the one or more holes, or openings, 18 in first tray6.

As would be apparent to one of skill in the art, opening 18 and cannulae30 can also be used to place, supply, or insert various types ofmicro-instruments into one or more periodontal pockets 5. Thus, giventhe device that one desires to insert through cannulae 30, cannulae 30can be appropriately designed to accommodate such devices.

FIG. 11 is an illustration of a barbed broach, or point, 40 placed intoa periodontal defect, or pocket, 5. The tooth is 2, the bone holding thetooth in 3, and the gum tissue 4. FIG. 12 illustrates a tray layer K.which is designed to accept a medicament capsule J. Cut-out N. accepts ahard tray layer L. and crushes the medicament layer. FIGS. 13A through13F are flow charts detailing multiple methods of the present invention.

In one embodiment, the invention described here allows for repeatabledelivery of medicaments into a periodontal pocket through the creationof a true syringe when using the invention with a plunger pushed througha tube into the periodontal pocket. In another embodiment, the presentinvention also permits for repeatable curettage using fine instrumentspushed through the tubes into the periodontal pocket. In still anotherembodiment, the present invention permits for the repeatable lavage, byusing the tube to connect a source of medicated or non-medicated liquidsenergized, or not, directed into the periodontal pocket.

In another embodiment, the present invention relates to a periodontaltray system comprising: a first inner tray layer that is designed toconform to at least a portion of an individual's mouth, wherein thefirst inner tray layer is designed to have one or more indentations, orpockets, formed therein that correspond to at least one area ofperiodontal disease; and a second outer tray layer that is designed tooperatively engage the first inner tray layer, wherein the have one ormore indentations, or pockets, formed in the first inner tray layercontain one or more medicaments, or compounds, designed to treat one ormore aspects of periodontal disease, and wherein the second outer traylayer is designed to operatively engage the first inner tray layer so asto permit the delivery of the one or more medicaments, or compounds,contained in the one or more indentations, or pockets, formed in thefirst inner tray layer into the at least one area of periodontaldisease.

In still another embodiment, the present invention relates to aperiodontal tray system comprising: a first tray layer that is designedto conform to at least a portion of an individual's mouth, wherein thefirst inner tray layer is designed to have one or more openings thereinthat correspond to at least one area of periodontal disease, wherein theone or more openings formed in the first tray layer are designed tooperatively couple one or more syringes, or micro-syringes, and whereinthe one or more syringes, or micro-syringes, contain one or moremedicaments, or compounds, designed to treat one or more aspects ofperiodontal disease.

In still another embodiment, the present invention relates to aperiodontal tray system comprising: a first tray layer that is designedto conform to at least a portion of an individual's mouth, wherein thefirst inner tray layer is designed to have one or more openings thereinthat correspond to at least one area of periodontal disease, wherein oneor more openings formed in the first tray layer are designed tooperatively couple with unit-dose medicament capsules, and wherein theone or more capsules contain one or more medicaments, or compounds,designed to treat one or more aspects of periodontal disease. In oneembodiment, the capsules are then activated, crushed, punctured, orexploded with the application of either a second tray or other hand-helddevice that releases the medicament into the mouth.

In still another embodiment, the present invention relates to a methodto fabricate the periodontal tray system, the method comprising thesteps of: (i) placing one or more small barbed broaches into one or moreperiodontal pockets, wherein the one or more small barbed broaches aredesigned to function in conjunction with a dental molding material, orimpression material, that is used to duplicate various teeth and mouthstructures; (ii) creating a mold of one or more areas surrounding theone or more periodontal pockets, wherein the mold contains one or moreopenings formed therein that correspond to the placement of the one ormore small barbed broaches; and (iii) using the mold of Step (ii) aseither a periodontal tray, or as an impression to produce a periodontaltray, wherein the periodontal tray contains one or more openings thereinthat correspond to one or more periodontal pockets, wherein the one ormore openings are designed to connect to one or more treatment devices(e.g., a tube/syringe combination, or a syringe).

Regarding the micro-syringes discloses herein, such syringes have beenreduced in size to work with one or more tray systems which, in oneembodiment, permit the placement, or location, of one or more of thesemicro-syringes in the mouth of a patient in a desired area where, forexample, periodontal issues exist. Activation of such syringes can bedone with a second tray, or with other devices, such as timed triggers,hand held instruments that engage the micro-syringe and allow therelease of the plunger.

In another embodiment, the present invention relates to a micro-syringethat attaches to a tray that delivers medicaments into the mouth wherethe construction of the micro-syringe involves a micro spring loadedmedicament syringe that attaches to the one or more layers of a tray inaccordance with the present invention, and wherein loading is possiblethrough the compressing of a spring that holds a plunger back until theplunger is deployed by pressing a latch. As would be apparent to thoseof skill in the art, multiple micro-springs can be attached to a tray toprovide multiple sites therapeutic treatment

Although the invention has been described in detail with particularreference to certain embodiments detailed herein, other embodiments canachieve the same results. Variations and modifications of the presentinvention will be obvious to those skilled in the art and the presentinvention is intended to cover in the appended claims all suchmodifications and equivalents.

It is claimed:
 1. A periodontal tray system, comprising: a tray layerthat is designed to confirm to at least a portion of an individual'smouth, wherein the tray layer has an opening formed therein, wherein atleast one of a liquid or a periodontal aid passes through the openingformed in the tray layer and into an area of periodontal disease in theindividual's mouth, and wherein the at least one of the liquid or theperiodontal aid is designed to treat periodontal disease.
 2. Theperiodontal tray system of claim 1, wherein the liquid passes throughthe opening formed in the tray layer and into the area of periodontaldisease in the individual's mouth, further comprising: at least one of asyringe or a micro-syringe coupled to the tray layer, wherein the atleast one of the syringe or the micro-syringe is configured to deliverthe liquid through the opening formed in the tray layer and into thearea of periodontal disease in the individual's mouth.
 3. Theperiodontal tray system of claim 1, further comprising a fitting coupledto the tray layer, wherein the fitting is configured to receive the atleast one of the liquid or the periodontal aid from a device designed toprovide the at least one of the liquid or the periodontal aid, whereinthe fitting is further configured to deliver the at least one of theliquid or the periodontal aid through the opening formed in the traylayer and into the area of periodontal disease in the individual'smouth.
 4. A periodontal tray system, comprising: a tray layer that isdesigned to conform to at least a portion of an individual's mouth,wherein the tray layer has an opening formed therein; and at least oneof a syringe or a micro-syringe coupled to the tray layer, wherein theat least one of the syringe or the micro-syringe is configured todeliver a liquid through the opening formed in the tray layer and intoan area of periodontal disease in the individual's mouth, wherein theliquid is designed to treat periodontal disease.
 5. The periodontal traysystem of claim 4, wherein the tray layer is formed from at least one ofa resilient polymer, a flexible polymer, a plastic compound, an acrylic,synthetic rubber, natural rubber, or a compound that is moldable orfoldable using chemical curing or heat-based vacuum forming.
 6. Theperiodontal tray system of claim 4, wherein the tray layer is formedfrom ethylene-vinyl acetate (EVA).
 7. The periodontal tray system ofclaim 4, wherein the at least one of the syringe or the micro-syringecontains and delivers at least one of a steroid, an antifungal agent, asterilant, a conditioner, a fluoride, a dentin desensitizer, anantiviral, an anesthetic, an oxygenase, an enzyme, a peroxide, or abacterial strain.
 8. The periodontal tray system of claim 4, wherein theliquid is a medicament designed to treat periodontal disease.
 9. Theperiodontal tray system of claim 4 comprising the micro-syringe, whereinthe micro-syringe comprises: a housing that contains the liquid; abarrel within the housing; a spring coupled to the barrel, wherein thespring is compressible by the barrel; and a latch coupled to the barrel,wherein the latch is configured to be engaged with the housing when thebarrel compresses the spring, and wherein the latch, when engaged, isconfigured to be disengaged from the housing such that the spring pushesthe barrel and the barrel pushes the liquid from the micro-syringe intothe opening formed in the tray layer.
 10. The periodontal tray system ofclaim 9, wherein the latch is disengaged when contacted by at least oneof a disparate tray layer or an instrument.
 11. The periodontal traysystem of claim 9, wherein the latch is disengaged by a timed trigger.12. A periodontal tray system, comprising: a tray layer that is designedto conform to at least a portion of an individual's mouth, wherein thetray layer has an opening formed therein; and a fitting coupled to thetray layer, wherein the fitting is configured to receive at least one ofa liquid or a periodontal aid from a device designed to provide the atleast one of the liquid or the periodontal aid, wherein the fitting isfurther configured to deliver the at least one of the liquid or theperiodontal aid through the opening formed in the tray layer and into anarea of periodontal disease in the individual's mouth, and wherein theat least one of the liquid or the periodontal aid is designed to treatperiodontal disease.
 13. The periodontal tray system of claim 12,further comprising: a cannula, comprising: a first end coupled to thefitting; and a second end coupled to the device.
 14. The periodontaltray system of claim 12, wherein the device is a syringe.
 15. Theperiodontal tray system of claim 12, wherein the device is an irrigationsource.
 16. The periodontal tray system of claim 12, wherein theperiodontal aid is a micro-instrument configured to pass through theopening formed in the tray layer and into the area of periodontaldisease in the individual's mouth to cause curettage.
 17. Theperiodontal tray system of claim 12, wherein the periodontal aid is amicro-instrument that pushes the liquid through the opening formed inthe tray layer and into the area of periodontal disease in theindividual's mouth.
 18. The periodontal tray system of claim 12, whereinthe tray layer further has a second opening formed therein, furthercomprising: a second fitting coupled to the tray layer, wherein thesecond fitting is configured to receive the at least one of the liquidor the periodontal aid from the device, and wherein the second fittingis further configured to deliver the at least one of the liquid or theperiodontal aid through the second opening formed in the tray layer andinto a second area of periodontal disease in the individual's mouth. 19.The periodontal tray system of claim 18, further comprising: a firstcannula, comprising: a first end coupled to the fitting; and a secondend coupled to the device; and a second cannula, comprising: a first endcoupled to the second fitting; and a second end coupled to the device.20. The periodontal tray system of claim 19, further comprising aframework attached to the first cannula and the second cannula, whereinthe framework gangs the first cannula and the second cannula.